NACDS urges simple, single med document for patients

December 7, 2010

ALEXANDRIA, Va. — Simplify, simplify.

That’s the message chain pharmacy lobbyists conveyed to the Food and Drug Administration in November, as the National Association of Chain Drug Stores urged federal health officials to adopt a simpler means of communicating drug safety and efficacy information to patients. The message — conveyed in a letter from NACDS VP government affairs and public policy Kevin Nicholson to FDA commissioner Margaret Hamburg — came as the agency mulls new federal guidelines on patient package inserts and other prescription drug information.

Nicholson also asked the FDA to step up its efforts to clear the way for an approval pathway for generic versions of biologically engineered drugs.

NACDS, Nicholson told Hamburg, strongly endorses federal efforts to adopt a simpler, single medication information document for patients. The goal, he said, should be clear: easy-to-understand instructions and warnings about possible side effects of prescription medicines.

Such a document, Nicholson asserted, provides the “final link in the prescription supply chain,” and should be “standardized with respect to format and content.”

“Today, patients receive several different types of written medication information, developed by different sources that may be duplicative, incomplete or difficult to read and understand,” Nicholson pointed out. “This current system is not adequate to ensure that patients receive essential medication information.”

NACDS, he reminded Hamburg, was part of a coalition of pharmacy groups that urged the agency in 2008 to require drug suppliers to provide “a concise, plain-language document for patients” when they fill a prescription.

Among the group’s other priorities with the agency: adoption of “an abbreviated approval pathway for biogenerics.” Nicholson also applauded recent efforts by the FDA’s Center for Drug Evaluation and Research and its director, Janet Woodcock, to address lingering skepticism among “certain sectors of the public” about the therapeutic equivalence of generic drugs.

“We applaud Dr. Woodcock for acknowledging this skepticism and for making its resolution a high priority,” he added.

Poll

Poll

Which of the current U.S. Presidential hopefuls do you think would be best for your business?

Hillary Clinton

Jeb Bush

Donald Trump

Ted Cruz

Ben Carson

Scott Walker

Marco Rubio

Rand Paul

Chris Christie

Mike Huckabee

SPECIAL REPORTS

Pharmacy’s battle for recognition continues

Fifty years ago this summer, President Lyndon B. Johnson secured his place in history by signing into law the legislation that created Medicare and Medicaid. To commemorate the anniversary, Drug Store News has put together an exclusive report on the effect that Medicare and Medicaid have had on the retail pharmacy industry and how it has transformed the role of the pharmacist. more...

IN THIS ISSUE

In this issue, DSN profiles Rite Aid and how the company is achieving a vision to become a retail healthcare company that delivers a higher level of care to its communities; takes you on a tour of Sears; offers insight into millennial shoppers and more. Click here to view the issue.